Browse Device Recalls
2,276 FDA medical device safety recalls.
FDA Medical Device Recall Enforcement Database
Browse 2,276 FDA medical device recall enforcement actions. Each entry includes the device description, reason for recall, classification (Class I through III based on severity), recalling firm, and distribution details. Use the filters below to search by year, classification, state, or keyword.
Medical Device Recalls
Browse 2,276 FDA device recalls in 2022.
| Date | Product | Reason | Class | Firm |
|---|---|---|---|---|
| Apr 20, 2022 | Proteus235- Proton Therapy System: to produce and deliver a proton beam for ... | First layer of Uniform Scanning treatment fields is sometimes irradiated with incorrect Scanning ... | Class II | Ion Beam Applications S.A. |
| Apr 19, 2022 | LEGION NARROW PS OXIN SZ 6N RT and JRNY II BCS FEMORAL OXIN LT SZ 5 | It was reported that a JOURNEY II BCS Femoral OXIN LT SZ5 was in a box labelled as a LEGION NARRO... | Class II | Smith & Nephew Inc |
| Apr 19, 2022 | Product Name: TEG5000 Analyzer (07-022, 07-033) with TEG Analytical Software ... | When the TEG 5000 Analyzer including TEG Analytical Software is used with PlateletMapping (ADP or... | Class II | Haemonetics Corporation |
| Apr 18, 2022 | Back up batteries in Ventilators labeled as the following: a. CARESCAPE R860 ... | Insufficient battery backup power resulting in premature shutdown of the ventilator when not conn... | Class I | GE Healthcare, LLC |
| Apr 18, 2022 | Medfusion Syringe Pump Model: Model 4000-0100-50, Model 4000-0101-249, Model... | Multiple issues with the potential for interruption of therapy or over-infusion: 1. Primary Audi... | Class I | Smiths Medical ASD Inc. |
| Apr 18, 2022 | Medfusion Syringe Pump Models: 3500, 3500-0600-00, 3500-0600-01, 3500-0600-2... | Multiple issues with the potential for interruption of therapy or over-infusion: 1. Primary Audi... | Class I | Smiths Medical ASD Inc. |
| Apr 18, 2022 | Replacement back up batteries distributed on or after April 1, 2019, for CARE... | Insufficient battery backup power resulting in premature shutdown of the ventilator when not conn... | Class I | GE Healthcare, LLC |
| Apr 18, 2022 | progenamatrix Human Keratin Matrix, sterile, Rx, with the following model num... | Inner pouch seal may be inadequate resulting in lack of sterility. | Class II | ProgenaCare |
| Apr 17, 2022 | ProterixBio SARS-CoV-2 (RBD) IgG Antibody Test, and associated ProterixBio Dr... | FDA review concluded that the test is insufficiently supported by clinical performance data, and ... | Class II | PROTERIXBIO |
| Apr 14, 2022 | putty i-FACTOR Peptide Enhanced Bone Graft 1.0cc Syringe REF 700-010, PUTTY | Patient chart label contains incorrect Part Number and volume amount. | Class III | Cerapedics, Inc. |
| Apr 14, 2022 | Turbett Surgical Container, TS1500 | Devices were subject to unapproved rework processes. | Class II | Turbett Surgical, Inc. |
| Apr 14, 2022 | BioPlex 2200 REF 12000670 ToRC IgM Reagent Pack | Performance concerns for the CMV IgM analyte. Analyte has demonstrated variable elevated backgro... | Class II | Bio-Rad Laboratories, Inc. |
| Apr 14, 2022 | HeartWare HVAD Pump Implant Kit, a) Model Number 1104JP, b) Model Number MCS1... | The pump may have a welding defect that can lead the pump to malfunction. The issue is under inve... | Class I | Medtronic Inc |
| Apr 13, 2022 | Getinge CM320-2 CHAMBER WU Series Washer Disinfector- For Use as a multi-cham... | Verification of installation not documented or may be incomplete, could result in harm to the use... | Class II | Getinge Usa Sales Inc |
| Apr 13, 2022 | NaviCare Nurse Call System provides a comprehensive communication and info... | Firm discovered a firmware memory leak with a supplier-manufactured component. | Class II | Baxter Healthcare Corporation |
| Apr 13, 2022 | AUTOLITH Touch 1.9F 375cm Biliary Electrohydraulic Lithotripter Probe | Product labeled incorrectly. | Class II | Northgate Technologies, Inc. |
| Apr 13, 2022 | Sensis, Programmable Diagnostic Computer, Model Nos. 6623974 ... | Siemens has become aware of three potential software issues with AXIOM Sensis or Sensis/ Sensis L... | Class II | Siemens Medical Solutions USA, Inc |
| Apr 13, 2022 | Getinge CM320 WUWD Series Washer Disinfector-For use as a multi-chamber washe... | Verification of installation not documented or may be incomplete, could result in harm to the use... | Class II | Getinge Usa Sales Inc |
| Apr 13, 2022 | Atellica IM 1600 Analyzer - automated, immunoassay analyzer designed to perfo... | Lots incompatible with Test Definition (TDef) Version 1.4, potentially lead to the generation of... | Class II | Siemens Healthcare Diagnostics, Inc. |
| Apr 13, 2022 | Voalte Nurse Call System provides a comprehensive communication and inform... | Firm discovered a firmware memory leak with a supplier-manufactured component. | Class II | Baxter Healthcare Corporation |
| Apr 13, 2022 | GMK Efficiency - GMK Sphere CR Insert Instrument Set Size 1 | A Size 2 trial baseplate was assembled with Size 1 instrument sets. | Class II | Medacta Usa Inc |
| Apr 13, 2022 | Atellica IM 1300 Analyzer - automated, immunoassay analyzer designed to perfo... | Lots incompatible with Test Definition (TDef) Version 1.4, potentially lead to the generation of... | Class II | Siemens Healthcare Diagnostics, Inc. |
| Apr 12, 2022 | Cobalt Models loaded with CareLink SmartSync Device Manager application softw... | Telemetry error that may occur with Medtronic Cobalt and Crome implantable cardioverter defibrill... | Class II | Medtronic Inc., Cardiac Rhythm and Heart Failur... |
| Apr 12, 2022 | Crome Models loaded with CareLink SmartSync Device Manager application softwa... | Telemetry error that may occur with Medtronic Cobalt and Crome implantable cardioverter defibrill... | Class II | Medtronic Inc., Cardiac Rhythm and Heart Failur... |
| Apr 11, 2022 | Artis icono floor-angiography systems developed for single and biplane diagno... | if the protective earth is interrupted and an additional fault leads to a fault current, the dete... | Class II | Siemens Medical Solutions USA, Inc |
| Apr 11, 2022 | (1) Teleflex Flex tube, Product #20011, sterile; (2) Teleflex Smooth-Flo Fle... | Reports received of torn corrugated breathing tubes. | Class II | TELEFLEX MEDICAL INC |
| Apr 11, 2022 | Artis icono biplane -angiography systems developed for single and biplane dia... | if the protective earth is interrupted and an additional fault leads to a fault current, the dete... | Class II | Siemens Medical Solutions USA, Inc |
| Apr 11, 2022 | AC-powered adjustable medical beds with built-in electric DC actuators and c... | There is a potential hazard of uninterrupted motion of the Motorized Wheel System due to the poss... | Class II | Umano Medical, Inc. |
| Apr 11, 2022 | (1) Gibeck Humid-Vent 2S Flex DC, Product #17731, sterile; (2) Gibeck Humid-... | Reports received of torn corrugated breathing tubes. | Class II | TELEFLEX MEDICAL INC |
| Apr 11, 2022 | AC-powered adjustable medical beds with built-in electric DC actuators and co... | There is a potential hazard of uninterrupted motion of the Motorized Wheel System due to the poss... | Class II | Umano Medical, Inc. |
| Apr 9, 2022 | Oral Rapid SARS-CoV-2 Antigen Rapid Test Kit; COVID 19 Test | Firm distributed tests which have not been cleared or authorized for marketing or distribution in... | Class I | Woodside Acquisitions Inc. |
| Apr 9, 2022 | Joysbio SARS-CoV-2 Antigen Rapid Test Kit (Colloidal Gold); COVID 19 Test | Firm distributed tests which have not been cleared or authorized for marketing or distribution in... | Class I | Woodside Acquisitions Inc. |
| Apr 8, 2022 | TMJ Arthroscopy Drape, 85''x 96'' | Latex content in product was labeled incorrectly as latex free. | Class II | Microtek Medical Inc. |
| Apr 8, 2022 | XVIVO Organ Chamber REF 19020 | The weld seal of the primary pouch was incomplete, and the sterility of the product cannot be ens... | Class II | XVIVO PERFUSION AB |
| Apr 8, 2022 | HemosIL ReadiPlasTin, Part No. 0020301400 | Variable and out of specification QC results with HemosIL ReadiPlasTin. IL will remove all lots ... | Class II | Instrumentation Laboratory |
| Apr 8, 2022 | Radiometer, REF:956-552, PIC050- Arterial Blood Sampler 1 X 2 mL, 80 IU elect... | Arterial Blood Sampler sterility cannot be guaranteed throughout the shelf life of the product. | Class II | Radiometer Medical ApS |
| Apr 7, 2022 | Resin UPDATE CD-ROM, REF: 250-3020 inside VARIANTnbs Sickle Cell Program Reor... | The problem is with the Bio-Rad VARIANT nbs Sickle Cell Program Resin Update CD-ROM software; Mod... | Class II | Bio-Rad Laboratories, Inc. |
| Apr 7, 2022 | NanoSight NS300 | Product found to not comply to Class 1 Laser safety requirement. | Class II | MALVERN PANALYTICAL LTD |
| Apr 7, 2022 | Radial Head Replacement System Implant is a one-piece, stemmed radial head re... | DePuy Synthes Radial Head Replacement System Contraindications added to Electronic Instructions f... | Class II | Synthes (USA) Products LLC |
| Apr 6, 2022 | Accula SARS-CoV-2 Test, REF: COV4100 | SARS-CoV-2 Test has an increased potential for false positive results, which may lead to a delay ... | Class I | MESA BIOTECH, INC |
| Apr 6, 2022 | V8 Immunodisplacement Kit REF 1803 | Due to microbial growth causing interference with interpretation. | Class II | Helena Laboratories, Corp. |
| Apr 6, 2022 | TRAY RING COVER, REF OM271000, CONTAINS (1) TRAY RING COVER, STERILE R, Rx Only, | Potential breach in the sterility barrier for tray ring covers. | Class II | Johnson & Johnson Surgical Vision Inc |
| Apr 5, 2022 | Sara Plus Active Floor Lift | The device may emit smoke or ignite. | Class I | ARJOHUNTLEIGH POLSKA Sp. z.o.o. |
| Apr 5, 2022 | The following first aid kits and cabinets containing components Medi-First XS... | First aid kit and cabinet components are being recalled by the supplier due to cGMP deviations at... | Class II | Certified Safety Mfg Inc |
| Apr 5, 2022 | Verigene Processor SP, Models 10-0000-07/10-0000-07R a component of the Veri... | Heater within the Verigene System may be outside of established temperature limits for assays wh... | Class II | Luminex Corporation |
| Apr 4, 2022 | Diagnostic Kit SARS-cCo V Antigen Rapid Test | COVID-19/SARS-CoV-2 Antigen Tests did not receive FDA Emergency Use Authorization, nor were the t... | Class II | USA Medical, LLC |
| Apr 1, 2022 | 11278V 11278VK CMOS Video Ureteroscope Z17744US-A (04/2016); 11278VA 11278VA... | Failure to achieve the expected six-log reduction in microorganisms following the disinfection pr... | Class II | Karl Storz Endoscopy |
| Apr 1, 2022 | 11272VN 11272VNK Flexible Video Urethro Cystoscope Z18442US-BD (08/2018); 11... | Failure to achieve the expected six-log reduction in microorganisms following the disinfection pr... | Class II | Karl Storz Endoscopy |
| Apr 1, 2022 | VITRIGUARD, CARRIER, CLEAR; Model. No. 43782001 The VitriGuard device is a... | Products in this lot may have compromised barrier seals, introducing a risk to sterility. | Class II | CooperSurgical, Inc. |
| Apr 1, 2022 | 11001RD1 11001RDK1 KARL STORZ Slim Nasopharyngolaryngoscope 96216006US V5.0 ... | Failure to achieve the expected six-log reduction in microorganisms following the disinfection pr... | Class II | Karl Storz Endoscopy |
Frequently Asked Questions
When a device safety issue is identified, the manufacturer or FDA initiates a recall. The FDA publishes an enforcement report detailing the device, the reason for the recall, and distribution. Healthcare facilities and providers are notified to check their inventory and take corrective action.
All types — from simple devices like blood glucose test strips and surgical gloves to complex devices like pacemakers, defibrillators, insulin pumps, hip implants, and ventilators. Software-driven devices are increasingly common in recalls due to bugs and cybersecurity vulnerabilities.
Use the search and filter tools on this page. Each recall entry includes the device description, model numbers, and distribution details so you can determine if your device is affected. Contact your healthcare provider if you find a match.